Download URGENT - Field Safety Notice

Field Safety Notice
Philips Healthcare
BIU iXR
-1/2-
FSN: MA-FCO 72200237
XCR603-130267/tv
October 2013
URGENT - Field Safety Notice
Philips HaemoSphere R4.1
Calculation of the vascular resistances in the Philips HaemoSphere R4.1 evo,
natal/ped in the special case of a shunt vitium.
Software update and IFU update.
Dear Customer,
A problem has been detected in the Philips HaemoSphere R4.1, Haemodynamic Catheter measuring
station, that will lead to an incorrect calculation of the pulmonary resistance. This Field Safety Notice,
72200237 is intended to inform you about:
 what the problem is and under what circumstances it can occur
 the actions that should be taken by the customer / user in order to prevent risks for patients or users
 the actions planned by Philips to correct the problem.
This document contains important information for the continued safe and
proper use of your equipment
Please review the following information with all members of your staff who need to be aware of the
contents of this communication. It is important to understand the implications of this communication.
Please retain a copy with the equipment Instruction for Use.
If you need any further information or support concerning this issue, please contact your local Philips
representative:
 0800 80 3000
This notice has been reported to the appropriate Regulatory Agency.
Philips apologizes for any inconveniences caused by this problem.
Sincerely,
H. de Jong
Sr. Director Q&R BIU: iXR
© KONINKLIJKE PHILIPS ELECTRONICS N.V. 2008
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means,
electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.
Form: UXW-060003a2
/ 2007-12-18
Field Safety Notice
Philips Healthcare
BIU iXR
-2/2-
FSN: MA-FCO 72200237
XCR603-130267/tv
October 2013
URGENT - Field Safety Notice
Philips HaemoSphere R4.1
Calculation of the vascular resistances in the Philips HaemoSphere R4.1 evo,
natal/ped in the special case of a shunt vitium.
Software update and IFU update.
AFFECTED PRODUCTS
System:
Philips HaemoSphere R4.1
Productcode:
722060
PROBLEM
DESCRIPTION
The software of the Philips Haemo 4.1 calculates lesser circulation resistance (RP
and RPI) from the difference between the mean pulmonary arterial and pulmonary
venous pressure (or LA mean pressure) divided by the heart minute volume.
This calculation method leads to a correct result, except in the special case of a
shunt vitum. In this case, the calculation method that is used can lead to an
incorrect calculation of pulmonary resistance. This contradicts the information in
the user manual.
HAZARD INVOLVED
As a result, clinical users could incorrectly consider the calculated pulmonary
resistance valid even in case of a shunt vitium. With the exclusive, uncritical
evaluation of this parameter, therapeutic decisions based on it could be incorrect.
HOW TO IDENTIFY
AFFECTED PRODUCTS
All Philips HaemoSphere R4.1 systems as indicated in the “Affected Products”
section mentioned above. A Unit Affected List (UAL) is provided to the local Philips
representatives.
Customers with affected systems will be contacted directly by the local Philips
Organization.
ACTION TO BE TAKEN
BY CUSTOMER / USER
The calculation for the vascular resistances may not be used in the presence of a
shunt vitium.
ACTIONS PLANNED BY
PHILIPS
A Mandatory Field Safety Corrective Action will be issued to solve this problem.
This Field Change Order (FCO) will be identified as FCO72200237 and will be free
of charge.
 This FCO consists of a SoftWare update which, in cases where a shunt
calculation was previously performed, ensures that the specific flows
determined using the shunt calculation are used for the resistance
calculation, so that in this case the vascular resistances can also be
determined correctly even in the presence of a shunt vitium.
 This FCO consists of an IFU update with a corrected text of the Chapter:
“Vascular resistances”.
The expected date of this FCO will be Q4, 2013
FURTHER
INFORMATION AND
SUPPORT
If you need any further information or support concerning this issue, please
contact your local Philips representative:
 0800 80 3000
© KONINKLIJKE PHILIPS ELECTRONICS N.V. 2008
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means,
electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.
Form: UXW-060003a2
/ 2007-12-18